CA2522961A1 - Tamper evident vacuum tube holder assembly and needle hub assembly therefor - Google Patents

Tamper evident vacuum tube holder assembly and needle hub assembly therefor Download PDF

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Publication number
CA2522961A1
CA2522961A1 CA002522961A CA2522961A CA2522961A1 CA 2522961 A1 CA2522961 A1 CA 2522961A1 CA 002522961 A CA002522961 A CA 002522961A CA 2522961 A CA2522961 A CA 2522961A CA 2522961 A1 CA2522961 A1 CA 2522961A1
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Canada
Prior art keywords
neck
needle
cover
needle hub
extending
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002522961A
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French (fr)
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CA2522961C (en
Inventor
William T. Torris
Glynn Clements
Gregory J. Brown
Ian Carr
Christian Schlerf
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Smiths Medical ASD Inc
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Individual
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Priority claimed from US10/419,934 external-priority patent/US8172808B2/en
Application filed by Individual filed Critical Individual
Publication of CA2522961A1 publication Critical patent/CA2522961A1/en
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Publication of CA2522961C publication Critical patent/CA2522961C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3216Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150473Double-ended needles, e.g. used with pre-evacuated sampling tubes
    • A61B5/150496Details of construction of hub, i.e. element used to attach the double-ended needle to a piercing device or sampling device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150541Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
    • A61B5/150549Protectors removed by rotational movement, e.g. torsion or screwing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150572Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058Joining techniques used for protective means
    • A61B5/150618Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150664Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
    • A61B5/150671Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element comprising means to impede repositioning of protection sleeve from covering to uncovering position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150732Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154Devices using pre-evacuated means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3117Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • A61M2005/312Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49826Assembling or joining

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Environmental & Geological Engineering (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packaging Of Annular Or Rod-Shaped Articles, Wearing Apparel, Cassettes, Or The Like (AREA)

Abstract

A vacuum tube holder (2) is fitted with a hub assembly (38). A needle protection device (72) is rotatably mounted to the neck (10) of vacuum tube holder. One portion (20a, 20b) of a locking mechanism is provided at the neck of the one piece vacuum tube holder and a second portion (54a, 54b) of the locking mechanism is provided at the needle hub of the needle hub assembly, so that when the needle hub assembly is press fit to the vacuum tube holder. The vaccum tube holder is also configured to have a needle cover integrally extending from its neck. A tamper evident notched joint is provided at the junction where the needle cover is connected to the neck. A finger grasp mechanism, in the shape of a wing nut (80), may be couples to the needle cover.

Claims (57)

Claims
1. Apparatus, comprising:

a cylindrical body having an opening at one end through which a fluid storage tube is insertable and a neck that has an elongate needle cover integrally extending therefrom, said cover being integrally joined to said neck at a weakened joint, said cover separable from said neck at said weakened joint when a predetermined torque is applied to said cover relative to said body, said neck having an aperture dimensioned to accept a needle hub.
2. Apparatus of claim 1, wherein said neck comprises a first portion of a lock mechanism, and said needle hub comprises a second portion of said lock mechanism, wherein when said needle hub is inserted to said neck through said aperture, said first and second portions of said lock mechanism coact to fixedly maintain said needle assembly to said neck.
3. Apparatus of claim 1, wherein said neck comprises at least one side orifice and said needle hub comprises at least one catch, said catch fixedly latching to said side orifice of said neck when said needle hub is inserted to said neck through said aperture.
4. Apparatus of claim 1, wherein said neck comprises a circumferential protuberance at its outer surface to which a collar of a needle protection housing is rotatably mountable.
5. Apparatus of claim 1, wherein said needle hub is a part of a needle hub assembly comprising a base having a double ended needle extending therethrough, said needle hub including a proximal section having at least one catch and a distal section that is dimensioned to extend from a distal end of said neck when said needle hub is fully inserted to said aperture, said catch snappingly latching to a side orifice at said neck when said assembly is fully inserted to said aperture.
6. Apparatus of claim 1, wherein said needle cover, once separated from said neck at said joint, is not attachable back to said neck, said joint thereby providing a tamper evident seal for said apparatus.
7. Apparatus of claim 1, wherein said needle hub is a part of a needle hub assembly comprising a double ended needle, and wherein once said needle cover is separated from said neck at said joint to expose an end of said needle extending from said needle hub, a needle protection housing pivotally connected to a collar rotatably mounted about said neck is movable to cover said end of said needle to thereby prevent said end of said needle from being further exposed.
8. A needle hub assembly, comprising:

a base having a proximal section and a distal section;
a double ended needle extending through said base so that one end of said needle extends from the distal end of said distal section and an other end of said needle extends from the proximal end of said proximal section; and at least one catch formed at the outer surface of said proximal section;
wherein said assembly is adaptable to be inserted to the cavity of a cylindrical body through an open end of said body until said catch latches onto an orifice at a neck of said body.
9. Needle hub assembly of claim 8, further comprising:

a circumferential ledge formed at the intersection of said distal and proximal sections, said circumferential ledge maintaining said proximal section within said neck; and a plate integrally formed at the proximal end of said proximal section, said plate fittingly positioned into a recess formed at a junction of said body where said neck begins, said plate stopping further forward movement of said assembly in the cavity of said body, said assembly being fixedly retained within said body by the latching of said catch to said orifice and the positioning of said plate in said recess.
10. Needle hub assembly of claim 8, further comprising a barb extending from the proximal end of said proximal section in concentric relationship with a portion of said other needle extending from the proximal end of said proximal section, said barb holding an open end of a rubber boot covering said other needle.
11. Needle hub assembly of claim 8, wherein said neck comprises a plurality of orifices, said needle hub assembly further comprising at least two catches transversely formed at opposite sides of said proximal section, said catches each latching onto a corresponding one of said orifices at said neck when said assembly is inserted to the cavity of said cylindrical body through its open end, said body being closed at its other end when said assembly is inserted thereinto.
12 Needle hub assembly of claim 11, wherein said proximal section has a plurality of through slots each formed behind a corresponding one of said catches to provide flexibility for the transverse movements of said corresponding one catch.
13. Needle hub assembly of claim 8, wherein said cylindrical body has integrally extending from its neck a needle cover, an area at said body where said neck meets said needle cover being weakened circumferentially relative to the rest of said body so that said cover is removable from said body when a predetermined torque is applied to said cover relative to said body for exposing said one end of said needle, the aperture of said neck at said area being smaller than the aperture of the rest of said neck.
14. Needle hub assembly of claim 8, wherein said neck of said body comprises a circumferential protuberance at its outer surface whereto a collar of a needle protection housing is rotatably mounted; and wherein once said needle cover is separated from said neck at a weakened joint between said needle cover and said neck to expose said one end of said needle extending from the distal end of said distal section, a needle protection housing pivotally connected to said collar rotatably mounted to said protuberance is adapted to be pivoted in alignment with said needle to cover said one end of said needle.
15. A tube holder assembly, comprising:

a cylindrical body having an opening at one end through which a fluid storage tube is insertable, a neck having one lock mechanism formed transverse to a side thereof, and an elongate cover integrally extending from said neck and joined to said neck at a weakened joint; and a needle hub assembly having a proximal section and a distal section;
a double ended needle extending through said distal and proximal sections, and an other lock mechanism formed at the outer surface of said proximal section;
wherein said needle hub assembly is fixedly fitted within said body with at least said proximal section fitted within said neck and said one and other lock mechanisms in a locking relationship; and wherein said cover is separable from said neck at said weakened joint when a predetermined torque is applied to said cover relative to either said body or said neck.
16. Tube holder assembly of claim 15, further comprising:

a protuberance formed about the outer circumference of said neck;
a collar rotatably mounted about said protuberance of said neck;
a housing hingedly attached to said collar and rotatable about said neck;
wherein after said cover is separated from said neck, said housing is pivotable to a position in substantial alignment with the one end of said double ended needle extending from said distal section of said needle hub assembly for covering said one end of said double ended needle.
17. Tube holder assembly of claim 16, wherein said housing comprises at least one hook mechanism for fixedly grasping and maintaining said one end of said double ended needle within said housing when said housing is pivoted to cover said one end of said double ended needle.
18. Tube holder assembly of claim 16, wherein said one lock mechanism comprises a pair of orifices formed transversely at opposite sides of said neck and wherein said other lock mechanism comprises a pair of catches formed at opposite sides of the outer surface of said proximal section, each of said catches latching onto a corresponding one of said orifices when said needle hub assembly is inserted to said body and said proximal section is press fitted to said neck; and wherein said neck has an aperture dimensioned to accept said proximal section and at least a portion of said distal section of said needle hub assembly.
19. A one piece molded tube holder, comprising: a cylindrical body having a cavity and an opening at one end through which a fluid storage tube is insertable to said cavity, said body ending with a neck having at least one orifice formed transverse to a side thereof, said neck having an aperture smaller in dimension than said cavity, a needle cover integrally extending from the end of said neck away from said body, a notch formed circumferentially about the junction where said neck is joined to said cover to effect a weakened joint so that said cover may be separated from said neck by a predetermined torque being applied to said cover relative to said neck or said body.
20. Tube holder of claim 19, wherein said neck comprises a pair of orifices formed at opposite sides thereof.
21. A one piece molded needle hub assembly to be used with the tube holder of claim 19, comprising: a proximal section and a distal section, said proximal section dimensioned to fit to the aperture of the neck of said container, a double ended needle extending through said distal and proximal sections, a pair of catches formed at opposite sides of the outer circumference of said proximal section, and a through slot formed in said proximal section behind each of said catches to enable flexible movements of said catches transversely to said proximal section.
22. Needle hub assembly of claim 21, further comprising: a circumferential ledge formed at the intersection of said proximal and distal sections, a plate formed at the proximal end of said proximal section, said assembly being mated to said container by said proximal and distal sections being inserted to the cavity of said needle container and then to the aperture of said neck, said circumferential ledge preventing said proximal section from passing through said neck while said catches latch onto respective orifices formed at said neck to fixedly retain said needle hub assembly in place, said plate preventing further movement of said needle hub assembly by mating with a recess internally formed at the base of said neck.
23. A method of manufacturing a holder of fluid storage tubes, comprising the steps of:

a) forming a cylindrical body having an opening at one end through which a fluid storage tube is insertable into the cavity of said body;

b) forming a neck integral to said body having an aperture smaller in diameter than said opening of said body;

c) forming at least one orifice transverse to a side of said neck for accepting a catch from a needle hub to be inserted into said neck; and d) extending an elongate needle cover integrally from said neck.
24. Method of claim 23, further comprising the step of:

notching or thinning the junction where said needle cover is integrally extended from said neck so that a given torque applied to said cover relative to either said neck or said body will separate said needle cover from said neck.
25. A method of manufacturing a needle hub assembly to be assembled to a holder of fluid storage tubes, comprising the steps of:

a) forming a needle hub having a proximal section and a distal section about a double ended needle with one end of said needle extending from the distal end of said distal section and an other end of said needle extending from the proximal end of said proximal section;

b) forming a circumferential ledge at the intersection of said distal and proximal sections;

c) forming at least one catch at a side of said needle hub, said catch to be latching to a corresponding orifice at a neck of said holder for fixedly retaining said needle hub assembly within said holder.
26. A method of manufacturing a safety holder of fluid storage tubes, comprising the steps of:

a) forming a cylindrical body having an opening at one end through which a fluid storage tube is insertable into the cavity of said body;

b) forming a neck integral to said body having an aperture smaller in diameter than said opening of said body;
c) forming one lock mechanism transverse to a side of said neck;
d) extending an elongate needle cover integrally from said neck;
e) forming a needle hub about a double ended needle with one end of said needle extending from its distal end and an other end of said needle extending from its proximal end;
f) forming an other lock mechanism at said needle hub;
g) inserting said needle hub to the cavity of said body through said opening of said body; and h) press fitting said needle hub to said aperture of said neck until said one and other lock mechanisms coact to fixedly hold said needle hub to said neck with said one needle end extending from said needle hub into said needle cover and said other needle end extending from said needle hub into the cavity of said body where said fluid storage tube is insertable.
27. Method of claim 26, further comprising the step of:

notching or thinning the junction where said needle cover is integrally joined to said neck so that a given torque applied to said cover relative to either said neck or said body separates said needle cover from said neck.
28. Method of claim 26, wherein said step c comprises the step of forming a pair of orifices at opposite sides of said neck and said step f comprises the step of forming a pair of catches at opposite sides of said needle hub; and wherein said step e further comprises the step of press fitting said needle hub into said aperture of said neck until said catches each latch onto a corresponding one of said orifices to thereby fixedly retain said needle hub to said neck.
29. Method of claim 23, further comprising the step of forming a through slot behind each of said catches to provide flexibility for the transverse movements of said each catch.
30. Method of claim 26 , further comprising the steps of:
forming a proximal section and a distal section for said needle hub;
forming a circumferential ledge at the intersection of said proximal and distal sections, said ledge preventing said proximal section from being moved out of said neck; and forming a plate integrally at the proximal end of said proximal section, said plate preventing further forward movement of said needle hub once said needle hub is properly fitted to said neck.
31. Apparatus, comprising:
a cylindrical body having an opening at one end through which a fluid storage tube is insertable and a neck that has an elongate needle cover integrally extending therefrom, said cover being integrally joined to said neck at a weakened joint, finger grasp means coupled to said cover to enable said cover to be readily separable from said neck at said weakened joint when a predetermined torque is applied to said finger grasp means to rotate said cover relative to said body, said neck having an aperture dimensioned to accept a needle hub.
32. Apparatus of claim 31, wherein said finger grasp means comprises a wing nut having a bore adapted to fit over the needle cover of said body at a portion of said cover, a plurality of slots formed lengthwise along the inner circumferential surface of said bore, each slot riding on a corresponding rib formed longitudinally along substantially the length of said needle cover.
33. Apparatus of claim 32, wherein each wing of said wing nut has a leg supported by an upper surface of a collar rotatably mounted to the neck of the body, said wing nut being fixedly secured to said needle cover, a housing extending from said collar and pivotable to a position in alignment along the longitudinal axis of said body.
34. Apparatus of claim 31, wherein said finger twist means comprises a wing nut integrally formed at a portion of said needle cover, each of the wings of said wing nut having a leg, the legs of said wings and a plurality of other legs extending downwards from said wing nut resting on an upper surface of a collar rotatably mounted to the neck of the body, a housing extending from said collar, said housing pivotable to a position in alignment along the longitudinal axis of said cylindrical body.
35. Apparatus of claim 31, wherein said neck comprises a first portion of a lock mechanism, and said needle hub comprises a second portion of said lock mechanism, wherein when said needle hub is inserted to said neck through said aperture, said first and second portions of said lock mechanism coact to fixedly maintain said needle assembly to said neck.
36. Apparatus of claim 31, wherein said needle hub is a part of a needle hub assembly comprising a base having a double ended needle extending therethrough, said needle hub including a proximal section having at least one catch and a distal section that is dimensioned to extend from a distal end of said neck when said needle hub is fully inserted to said aperture, said catch snappingly latching to a side orifice at said neck when said assembly is fully inserted to said aperture.
37. Apparatus of claim 31, wherein said weakened joint integrally joining said needle cover to said neck of said body is manufactured to withstand up to approximately 60 ounce inches of torque before breaking; and wherein said needle cover, once separated from said neck at said joint, is not attachable back to said neck.
33. Apparatus of claim 31, wherein said needle cover is separable from said body when said predetermined torque applied to said finger grasp means is less than approximately 60 ounce inches.
39. Apparatus of claim 31, wherein said needle hub is a part of a needle hub assembly comprising a double ended needle, and wherein once said needle cover is separated from said neck at said joint to expose an end of said needle extending from said needle hub, a needle protection housing pivotally connected to a collar rotatably mounted to said neck is movable to cover said end of said needle to thereby prevent said end of said needle from being further exposed.
40. Apparatus of claim 31, wherein said finger grasp means comprises at least one wing integrally extending transversely from said needle cover.
41. A needle holder assembly, comprising:
a cylindrical body having an opening at one end through which a fluid storage tube is insertable, a neck having one lock mechanism formed transverse to a side thereof, an elongate cover integrally extending from said neck and joined to said neck at a weakened joint, and finger grasp means fixedly mounted to a portion of said elongate cover, said finger grasp means having at least one wing extending away from said elongate cover;
a needle hub assembly having a proximal section and a distal section, a double ended needle extending through said distal and proximal sections, and an other lock mechanism formed at the outer surface of said proximal section;
wherein said needle hub assembly is fixedly fitted within said body with at least said proximal section fitted within said neck and said one and other lock mechanisms in a locking relationship; and wherein said cover is separable from said neck at said weakened joint when a predetermined torque is applied to said wing relative to either said body or said neck.
42. Needle holder assembly of claim 41, further comprising:
a collar rotatably mounted about said neck;
a housing hingedly attached to said collar and rotatable about said neck;
wherein after said cover is separated from said neck, said housing is pivotable to a position in substantial alignment with the one end of said double ended needle extending from said distal section of said needle hub assembly for covering said one end of said double ended needle.
43. Needle holder assembly of claim 41, wherein said housing comprises at least one hook mechanism for fixedly grasping and maintaining said one end of said double ended needle within said housing when said housing is pivoted to cover said one end of said double ended needle.
44. Needle holder of claim 41, wherein said finger grasp means comprises a ring having a plurality of wings extending away from the outer wall of said ring, said wings each having a lower leg that rests on an upper surface of said collar, said ring including a plurality of slots along its inner wall that guidedly fit to corresponding ribs extending longitudinally along the length of said needle cover when said ring is fitted to said needle cover, said ring further having a plurality of extensions at its inner wall in contact with said needle cover.
45. Needle holder assembly of claim 41, wherein said one lock mechanism comprises a pair of orifices formed transversely at opposite sides of said neck and wherein said other lock mechanism comprises a pair of catches formed at opposite sides of the outer surface of said proximal section, each of said catches latching onto a corresponding one of said orifices when said needle hub assembly is inserted to said body and said proximal section is press fitted to said neck; and wherein said neck has an aperture dimensioned to accept said proximal section and at least a portion of said distal section of said needle hub assembly.
46. Needle holder assembly of claim 41, wherein said weakened joint integrally joining said needle cover to said neck of said body is manufactured to withstand up to approximately 60 ounce inches of torque before breaking; and wherein said needle cover, once separated from said neck at said joint, is not attachable back to said neck.
47. Needle holder assembly of claim 41, wherein said finger grasp means is integral to said cover.
48. A one piece molded needle holder, comprising: a cylindrical body having a cavity and an opening at one end through which a fluid storage tube is insertable to said cavity, said body ending with a neck having at least one orifice formed transverse to a side thereof, said neck having an aperture smaller in dimension than said cavity, a needle cover integrally joined to and extending from the end of said neck away from said body, a notch formed circumferentially about the junction where said neck is joined to said cover to effect a weakened joint, finger grasp means coupled to said needle cover to enable a user to twist off said needle cover from said neck by applying a predetermined torque thereto.
49. Needle holder of claim 48, wherein said neck comprises a pair of orifices formed at opposite sides thereof, said needle holder further comprising a collar having a housing pivotably attached thereto rotatably mounted about said neck, said housing pivotable to a position in alignment along the longitudinal axis of said holder for covering a needle extending from a needle assembly mated to said neck, a hook integral in said housing fixedly holding said needle once said housing is pivoted to said alignment position.
50. Needle holder of claim 48, wherein said finger grasp means comprises a wing nut, and said needle cover is separable from said body when said predetermined torque applied to said wing nut is less than approximately 60 ounce inches; and wherein said needle cover, once separated from said neck at said joint, is not attachable back to said neck.
51. A one piece molded needle hub assembly to be used with the molded needle holder of claim 48, comprising: a proximal section and a distal section, said proximal section dimensioned to fit to the aperture of the neck of said holder, a double ended needle extending through said distal and proximal sections, a pair of catches formed at opposite sides of the outer circumference of said proximal section, and a through slot formed in said proximal section behind each of said catches to enable flexible movements of said catch transversely to said proximal section.
52. A method of manufacturing a needle holder, comprising the steps of:
a) forming a cylindrical body having an opening at one end through which a fluid storage tube is insertable into the cavity of said body;

b) forming a neck integral to said body having an aperture smaller in diameter than said opening of said body;
c) forming at least one orifice transverse to a side of said neck for accepting a catch from a needle hub to be inserted into said neck;
d) extending an elongate needle cover integrally front said neck; and e) coupling a finger grasp means to said needle cover.
53. Method of claim 52, wherein said finger grasp means comprises a wing nut, said method further comprising the step of:
notching or thinning the junction where said needle cover is integrally extended from said neck so that a given torque applied to said wing nut relative to ether said neck or said body will separate said needle cover from said neck.
54. A method of manufacturing a needle holder, comprising the steps of:
a) forming a cylindrical body having an opening at one end through which a fluid storage tube is insertable into the cavity of said body;
b) forming a neck integral to said body having an aperture smaller in diameter than said opening of said body;
c) forming one lock mechanism transverse to a side of said neck;
d) extending an elongate needle cover integrally from said neck;
e) coupling a finger grasp means to said needle cover;
f) forming a needle hub assembly about a double ended needle with one end of said needle extending from its distal end and an other end of said needle extending from its proximal end;
g) forming an other lock mechanism at said needle hub assembly;
h) inserting said needle hub to the cavity of said body through said opening of said body; and I) press fitting said needle hub to said aperture of said neck until said one and other lock mechanisms coast to fixedly hold said needle hub to said neck with said one needle end extending from said needle hub into said needle cover and said other needle end extending from said needle hub into the cavity of said body where said fluid storage tube is to be inserted.
55. Method of claim 54, wherein said finger grasp means comprises a wing nut, said method further comprising the step of:
notching or thinning the junction where said needle cover is integrally joined to said neck so that a torque of less than approximately 60 ounce inches or greater applied to said wing nut relative to either said neck or said body will separate said needle cover from said neck.
56. Method of claim 54, wherein said step c comprises the step of forming a pair of orifices at opposite sides of said neck, and wherein said step g comprises the step of forming a pair of catches at opposite sides of said needle hub;
wherein said step a further comprises the step of press fitting said needle hub into said aperture of said neck until said catches each latch onto a corresponding one of said orifices to fixedly retain said needle hub to said neck.
57. Method of claim 54, wherein said step a comprises integrally forming said finger grasp means and said cover, said finger grasp means being a wing nut.
CA2522961A 2003-04-22 2004-04-22 Tamper evident vacuum tube holder assembly and needle hub assembly therefor Expired - Fee Related CA2522961C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US10/419,934 US8172808B2 (en) 2003-04-22 2003-04-22 Tamper evident vacuum tube holder assembly and needle hub assembly therefor
US10/419,934 2003-04-22
US10/827,434 2004-04-20
US10/827,434 US8672892B2 (en) 2003-04-22 2004-04-20 Tamper evident vacuum tube holder assembly and needle hub assembly therefor
PCT/US2004/012655 WO2004093938A2 (en) 2003-04-22 2004-04-22 Tamper evident vacuum tube holder assembly and needle hub assembly therefor

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EP (1) EP1620144B1 (en)
JP (1) JP4489765B2 (en)
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JP4489765B2 (en) 2010-06-23
EP1620144A2 (en) 2006-02-01
MXPA05011346A (en) 2006-05-19
US8672892B2 (en) 2014-03-18
CA2522961C (en) 2012-10-30
EP1620144B1 (en) 2018-01-24
US20130042458A1 (en) 2013-02-21
US8641679B2 (en) 2014-02-04
WO2004093938A3 (en) 2005-03-03
JP2006526466A (en) 2006-11-24
US20040254531A1 (en) 2004-12-16
WO2004093938A2 (en) 2004-11-04
EP1620144A4 (en) 2014-06-04

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